January 5th, 2006

Additional packaging safety innovations for Octagam®


Octapharma USA Inc. announced today that it has introduced several new packaging enhancements for Octagam® (immune globulin intravenous [human] 5%).

In response to customer feedback, the 5g (100ml) and 10g (200ml) presentations will now be packaged in new plasticized cartons.  These offer the advantage of improved strength and durability during transportation and handling.

Secondly, as part of Octapharma’s on-going Quality Assurance program additional measures have been implemented to increase the tamper-proof attributes of the packaging.  These changes are part of Octapharma’s global commitment to patients and to the safe and optimal use of plasma.

With immediate effect all batches of Octagam 5% shipped to the USA will be equipped with tamper-evident adhesive tape on both the top and bottom end of every individual carton.

	Picture 1

On the closed carton, this label is blue and opaque white (picture 1).

	Picture 2

After the first opening of the carton the Octapharma logo appears in blue (picture 2).

	Picture 3

If, re-closure of the carton is attempted the safety label displays the Octapharma logo in white (picture 3).

This existing tamper-evident safety measures will be maintained, i.e. each vial of Octagam is supplied with an integral flip top that cannot be reattached after opening and a unique ink-jet number printed on the cap which codes the batch ID.

“We are confident that taken together, these measures will improve the safety and integrity of Octagam by increasing the detection of unauthorized opening” said Judi Miller, Medical Affairs Director, Octapharma USA .

Customers are advised to carefully check each vial to ensure its integrity before use. If tampering is suspected, the product should not be opened or used and the incident should be reported as soon as possible to Octapharma by calling us toll free at 1-866-766-4860.